Illumina, Inc. announced that its MiSeqDx Sequencing System received the approval certificate from the China National Drug Administration (CNDA). This is Illumina’s first CNDA-cleared, next-generation sequencing (NGS) system in China. In accordance with the clearance, Illumina can now market and sell the MiSeqDx Sequencing System to hospitals and other medical institutions for in-vitro diagnostic (IVD) testing throughout China. Designed specifically for the clinical laboratory environment, the MiSeqDx Sequencing System is a benchtop sequencer that incorporates an easy-to-use workflow and data output tailored to the diverse needs of clinical labs. Taking advantage of proven Illumina sequencing by synthesis (SBS) chemistry, the MiSeqDx Sequencing System provides IVD developers the tools to create accurate diagnostic testing. Additionally, integrated software enables run setup, sample tracking, user management, audit trails and data interpretation.
“The clearance of the MiSeqDx in China is a significant milestone for Illumina because it provides more opportunities for NGS,” said Garret Hampton, Executive Vice President of Clinical Genomics at Illumina. “More medical institutions and patients will now have access to the latest NGS technology. We are encouraging more clinical companies to select the MiSeqDx System to develop new clinical assays and to help provide needed solutions to some of China’s greatest health challenges.” The MiSeqDx Sequencing System now has regulatory approval in the United States, China, Canada, Argentina, European countries recognizing the CE-IVD mark, Australia, South Korea, Singapore, Thailand, and the Philippines.